US5281522A
Expired / Lapsed
US
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Reagents and kits for determination of fetal fibronectin in a vaginal sample
Assignee: Cytyc Corp
•
Filing: 1990-12-14
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Granted: 1994-01-25
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Expires: 2010-12-14
Abstract
Abstract This invention relates to methods, reagents and kits for detection of normal or ectopic pregnancy, the termination of pregnancy, or increased risk of preterm labor and rupture of membranes. Each embodiment involves sampling from the vaginal cavity, and determining the presence or absence of a specific analyte in the test sample. Sandwich or competition assay procedures can be used. Reagents and reagent kits for the above assays are included. The kit contains anti-(fetal fibronectin) antibody and an anti-fibronectin antibody.
Inventors
- 👤 Andrew E. Senyei
- 👤 Nelson N. H. Teng
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 23:34
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/74; G01N33/76; C; C07; C07K; C07K16/00; C07K16/18; G01N33/53; G01N33/575; G01N33/5757; G01N33/68; G01N33/689; G01N2800/00; G01N2800/36; G01N2800/368
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
64 words
A kit for detecting fetal fibronectin in a vaginal sample comprising: a. an anti-(fetal fibronectin) antibody; b. an anti-fibronectin antibody, wherein either said anti-(fetal fibronectin) antibody or said anti-fibronectin antibody is adhered to an insoluble support; and c. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent.
Claim 2
Dependent Claim
64 words
A kit for detecting fetal fibronectin in a vaginal sample comprising: a. an anti-(fetal fibronectin) antibody; b. an anti-fibronectin antibody, wherein either said anti-(fetal fibronectin) antibody or said anti-fibronectin antibody is adhered to an insoluble support; and c. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent.
Claim 3
Dependent Claim
14 words
The kit of claim 1 wherein said anti-(fetal fibronectin) antibody is a monoclonal antibody.
Claim 4
Dependent Claim
12 words
The kit of claim 2 wherein said anti-(fetal fibronectin) antibody is FDC-6.
Claim 5
Dependent Claim
13 words
The kit of claim 1 wherein said anti-fibronectin antibody is a polyclonal antibody.
Claim 6
Dependent Claim
11 words
The kit of claim 4 wherein said anti-fibronectin antibody is labeled.
Claim 7
Dependent Claim
11 words
The kit of claim 5 wherein said label is an enzyme.
Claim 8
Dependent Claim
11 words
The kit of claim 6 wherein said enzyme is alkaline phosphatase.
Claim 9
Dependent Claim
12 words
The kit of claim 7 wherein said kit additionally comprises enzyme substrate.
Claim 10
Dependent Claim
12 words
The kit of claim 8 wherein said enzyme substrate is phenolphthalein monophosphate.
Claim 11
Dependent Claim
11 words
The kit of claim 5 wherein said label is colloidal gold.
Claim 12
Dependent Claim
22 words
The kit of claim 1 wherein said insoluble support comprises a microtiter plate or a strip of wells of a microtiter plate.
Claim 13
Dependent Claim
14 words
The kit of claim 11 wherein said kit additionally comprises a microtiter plate cover.
Claim 14
Dependent Claim
25 words
The kit of claim 11 wherein said kit includes a strip of wells of a microtiter plate and additionally comprises a holder for said strip.
Claim 15
Dependent Claim
13 words
The kit of claim 1 wherein said kit additionally comprises a positive, control.
Claim 16
Dependent Claim
18 words
The kit of claim 14 wherein said positive control is amniotic fluid of a known fetal fibronectin concentration.
Claim 17
Dependent Claim
18 words
The kit of claim 15 wherein said fetal fibronectin concentration is from about 10 to about 100 ng/mL.
Claim 18
Dependent Claim
42 words
The kit of claim 16 wherein said amniotic fluid is diluted in 0.05M Tris buffer pH 7.4, 1% bovine serum albumin, 0.15M sodium chloride, 0.02% Sodium Azide, 5 mM ethylenediamine tetraacetic acid, 1 mM phenylmethylsulfonyl fluoride, and 500 Kallikrein Units/ml of Aprotinin.
Claim 19
Dependent Claim
13 words
The kit of claim 1 wherein said kit additionally comprises a negative control.
Claim 20
Dependent Claim
40 words
The kit of claim 18 wherein said negative control is 0.05M Tris buffer pH 7.4, 1% bovine serum albumin, 0.15M sodium chloride, 0.02% Sodium Azide, 5 mM ethylenediamine tetraacetic acid, 1 mM phenylmethylsulfonyl fluoride, and 500 Kallikrein Units/ml of Aprotinin.
Claim 21
Dependent Claim
16 words
The kit of claim 1 wherein said kit additionally comprises at least one sample filtering device.
Claim 22
Dependent Claim
17 words
The kit of claim 20 wherein said sample filtering device dispenses a predetermined volume of filtered sample.
Claim 23
Dependent Claim
13 words
The kit of claim 1 wherein said kit additionally comprises a rinse buffer.
Claim 24
Dependent Claim
18 words
The kit of claim 22 wherein said rinse buffer is 0.02M Tris, 0.08M sodium chloride and 0.05% Tween-20.
Claim 25
Dependent Claim
13 words
The kit of claim 23 wherein said rinse buffer additionally comprises sodium azide.
Claim 26
Dependent Claim
14 words
The kit of claim 23 wherein said rinse solution is packaged in concentrated form.
Claim 27
Dependent Claim
12 words
The kit of claim 1 wherein said unsoluble support is a membrane.
Claim 28
Dependent Claim
10 words
The kit of claim 26 wherein said membrane is nylon.
Claim 29
Dependent Claim
14 words
The kit of claim 26 wherein said membrane is placed over an absorbent layer.
Claim 30
Dependent Claim
18 words
The kit of claim 28 wherein a flow control layer is intermediate said membrane and said absorbent layer.
Claim 31
Dependent Claim
19 words
The kit of claim 26 wherein said kit additionally comprises a sample filtering device which contains labeled anti-fibronectin antibody.
Claim 32
Dependent Claim
45 words
The kit of claim 7 wherein the alkaline phosphatase-labeled anti-fibronectin antibody is in an enzyme conjugate buffer comprising 50 mM Tris, pH 7.2; 2% D-Sorbitol; 2% bovine serum albumin; 0.01% Tween-20; 1 mM MgCl 2 ; 0.1% ZnCl 2 ; and optionally 0.1% sodium azide.
Claim 33
Dependent Claim
21 words
The kit of claim 9 wherein the phenolphthalein monophosphate is in an enzyme substrate solution containing 2-amino-2-methyl-1-propanol and MgCl 2 .
Claim 34
Dependent Claim
29 words
The kit of claim 32 wherein said enzyme substrate solution comprises 1 mg/ml phenolphthalein monophosphate; 0.4M 2-amino-2-methyl-1-propanol, pH 10; 0.1 mM MgCl 2 ; and, optionally 0.2% sodium azide.
Claim 35
Dependent Claim
36 words
The kit of claim 10 wherein the gold-labeled anti-fibronectin antibody conjugate is in a protein matrix in a conjugate buffer comprising 15 mM Tris; 0.1% Tween 20; 0.2% polyethylene glycol; 8% polyvinylpyrrolidine; and, optionally 0.04% thimerosal.
Claim 36
Dependent Claim
14 words
The kit of claim 34 wherein the protein matrix comprises 2% bovine serum albumin.
Claim 37
Dependent Claim
11 words
The kit of claim 35 wherein said antibody conjugate is lyophilized.
Claim 38
Dependent Claim
13 words
The kit of claim 36 wherein said kit includes a conjugate reconstitution buffer.
Claim 39
Dependent Claim
15 words
The kit of claim 37 wherein said conjugate reconstitution buffer comprises 100 mM sodium acetate.
Claim 40
Dependent Claim
14 words
The kit of claim 1 wherein said device is a vaginal sample collection device.
Claim 41
Dependent Claim
11 words
The kit of claim 1 wherein said device comprises a swab.
Claim 42
Dependent Claim
12 words
The kit of claim 40 wherein said swab is a dacron swab.
Claim 43
Dependent Claim
120 words
A kit for detecting a fetal fibronectin in a vaginal sample comprising: a. an anti-(fetal fibronectin) antibody adhered to a well of a microtiter plate; b. an alkaline phosphatase-labeled anti-fibronectin antibody in an enzyme conjugate buffer comprising 50 mM Tris, pH 7.2; 2% D-Sorbitol; 2% bovine serum albumin; 0.01% Tween-20; 1 mM MgCl 2 ; 0.1% ZnCl 2 ; and optionally 0.1% sodium azide; c. phenolphthalein monophosphate is in a enzyme substrate solution comprising 1 mg/ml phenolphthalein monophosphate; 0.4M 2-amino-2-methyl-1-propanol, pH 10; 0.1 mM MgCl 2 ; and, optionally 0.2% sodium azide; and d. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent.
Claim 44
Dependent Claim
120 words
A kit for detecting a fetal fibronectin in a vaginal sample comprising: a. an anti-(fetal fibronectin) antibody adhered to a well of a microtiter plate; b. an alkaline phosphatase-labeled anti-fibronectin antibody in an enzyme conjugate buffer comprising 50 mM Tris, pH 7.2; 2% D-Sorbitol; 2% bovine serum albumin; 0.01% Tween-20; 1 mM MgCl 2 ; 0.1% ZnCl 2 ; and optionally 0.1% sodium azide; c. phenolphthalein monophosphate is in a enzyme substrate solution comprising 1 mg/ml phenolphthalein monophosphate; 0.4M 2-amino-2-methyl-1-propanol, pH 10; 0.1 mM MgCl 2 ; and, optionally 0.2% sodium azide; and d. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent.
Claim 45
Dependent Claim
28 words
The kit of claim 42 wherein the kit additionally contains a rinse buffer concentrate comprising 0.1M Tris, pH 7.4; 4.0M NaCl; 2.5% Tween-20; and, optionally 1.0% sodium azide.
Claim 46
Dependent Claim
16 words
The kit of claim 42 wherein the kit additionally comprises a positive and a negative control.
Claim 47
Dependent Claim
79 words
A kit for detecting a fetal fibronectin in a test sample comprising: a. an anti-(fetal fibronectin) antibody adhered to a nylon membrane, said membrane placed over an absorbent layer and having a flow control layer intermediate said membrane and said absorbent layer; b. a lyophilized gold-labeled anti-fibronectin antibody conjugate comprising 15 mM Tris; 2% bovine serum albumin; 0.1% Tween 20; 0.2% polyethylene glycol; 8% polyvinylpyrrolidine; and, optionally 0.04% thimerosal; and c. a reconstitution buffer comprising 100 mM sodium acetate.
Claim 48
Dependent Claim
79 words
A kit for detecting a fetal fibronectin in a test sample comprising: a. an anti-(fetal fibronectin) antibody adhered to a nylon membrane, said membrane placed over an absorbent layer and having a flow control layer intermediate said membrane and said absorbent layer; b. a lyophilized gold-labeled anti-fibronectin antibody conjugate comprising 15 mM Tris; 2% bovine serum albumin; 0.1% Tween 20; 0.2% polyethylene glycol; 8% polyvinylpyrrolidine; and, optionally 0.04% thimerosal; and c. a reconstitution buffer comprising 100 mM sodium acetate.
Claim 49
Dependent Claim
16 words
The kit of claim 45 wherein said membrane additionally includes a control region comprising membrane-affixed fibronectin.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-01-24 | 1997-07-26 | 1998-01-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-01-24 | 2001-07-26 | 2002-01-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-01-24 | 2005-07-26 | 2006-01-25 | $7700.00 | Window Closed / Lapsed |